Model Number NIPG1500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Paralysis (1997)
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Event Date 07/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device was not explanted.The manufacturing records were reviewed and no non-conformities were found.
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Event Description
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It was reported to nevro that about one year after implant, the patient recently felt paralyzed in the lower left back.The patient was advised to contact their physician.Nevro had attempted to obtain additional information regarding the nature of the symptoms but was unsuccessful.There have been no reports of further complications regarding this event.
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Manufacturer Narrative
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Follow-up indicated that the patient was still experiencing right leg paralysis and urinary incontinence.The patient continues to be under supervision of their physician and is currently using the device to find effective pain relief.
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Search Alerts/Recalls
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